Clinical Report: Approval of Lisaftoclax for CLL and SLL in China
Overview
Lisaftoclax has been approved in China for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received prior systemic therapy. This approval is notable as it is only the second B-cell lymphoma 2 (Bcl-2) inhibitor approved globally since venetoclax in 2016.
Background
The treatment landscape for CLL and SLL has been evolving, with a need for new therapeutic options, particularly for patients who have experienced disease progression on existing treatments. The approval of lisaftoclax represents a development in targeted therapy.
Data Highlights
| Study | Objective Response Rate | Patient Cohorts |
|---|---|---|
| Phase 1b/2 Study (NCT04215809) | 62.5% | Relapsed/Refractory and Treatment-Naïve |
Key Findings
- Lisaftoclax is the first Bcl-2 inhibitor approved for CLL/SLL in China.
- Approval followed a phase 1b/2 study demonstrating a 62.5% objective response rate.
- Lisaftoclax offers a new treatment option for patients who have progressed on venetoclax.
Clinical Implications
The approval of lisaftoclax provides clinicians with a new therapeutic option for managing CLL and SLL.
Conclusion
The introduction of lisaftoclax into the treatment paradigm for CLL and SLL signifies an important milestone in oncology.
Related Resources & Content
- Author(s)/Org, Source, Year -- Title
- NCCN Guidelines® Insights: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 2.2026.
- Safety, tolerability, and pharmacokinetics of lisaftoclax (APG-2575)-based therapy in patients with chronic lymphocytic leukemia: Phase 1b/2 study
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- Lisaftoclax: First Approval - PubMed
- NCCN Guidelines® Insights: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 2.2026.
- Safety, tolerability, and pharmacokinetics of lisaftoclax (APG-2575)-based therapy in patients with chronic lymphocytic leukemia: Phase 1b/2 study - PubMed
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